a phase 3 study to evaluate the efficacy and safety of resiniferatoxin for pain due to osteoarthritis of the knee

Conditions: Osteoarthritis, Knee; Knee Pain Chronic

Summary: this study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

this study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (oa).

Eligibility criteria:
key inclusion criteria: * male or female 35 to 85 years of age (inclusive). * diagnosis of moderate to severe pain in the index knee due to oa. * pain in the non-index knee is less than pain in the index knee. * body mass index ≤40 kg/m². * experienced treatment failure with at least 2 prior categories of therapies. * able to understand and complete study-related forms and communicate with the investigator and/or site staff. key exclusion criteria: * evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia. * history of or current condition of poorly controlled hypertension, qtc prolongation, history of risk factors for torsades de pointes, or family history of long qt syndrome; or is using concomitant medications that prolong the qt interval. * received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day. * pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone oa, or knee pain attributable to disease other than oa. * instability or misalignment in the index knee. * concurrent use of opioids or indications other than knee pain. * history within the past 2 years of substance abuse, including alcohol. * allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents. * female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding. * any medical condition or comorbidities that, in the investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments. * sensory peripheral neuropathy that is of moderate severity or higher. * arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within the past 12 months. * known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis b or hepatitis c. participants with these viral infections who are receiving or have received antiviral treatment and have a viral load that is undetectable are eligible. * concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee joint including chondromalacia patellae, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint. * undergone arthroscopic surgery of the index knee within 6 months of the injection day, or open surgery to the index knee within 24 months of the injection day. * undergone replacement surgery of the index knee. * presence of surgical hardware or other foreign bodies in the index knee.